Argenx Se · EURONEXT:ARGX
Argenx — Corporate Update (June 2024)
21 slides from Argenx's corporate update, Jun 21, 2024
Slide 1: VYVGART Hytrulo Now Indicated for CIDP
FDA APPROVAL CALL | JUNE 21, 2024 VYVGART HYTRULO ® NOW INDICATED FOR CIDP
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or
Slide 3: Approval Overview
Approval Overview T I M VA N H A U W E R ME I R E N
Slide 4: VYVGART Hytrulo Now FDA-Approved for CIDP
VYVGART Hytrulo Now FDA-Approved for CIDP 2024 1958* 1979* 1985* First and only targeted IgG Fc-antibody fragment† Corticosteroids PLEX IG • Non-plasma derived biologic therapy for CIDP • Targets FcRn, reducing IgG antibodies, including pathogenic autoantibodies VYVGART Hytrulo is a coformulation of
Slide 5: Highlights of U.S. Prescribing Information
Highlights of U.S. Prescribing Information INDICATION STATEMENT VYVGART Hytrulo is a neonatal Fc receptor blocker indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) DOSING AND ADMINISTRATION • Evaluate need to administer age-appropriate vaccin
Slide 6: CIDP Patients Need New Options
CIDP Patients Need New Options Significant pain, numbness in hands and feet 80% report difficulty standing1 >50% Feelings of dissatisfied with symptom burden2 isolation and depression ≤20% 88% achieve remission on current SOC3 have residual neurological symptoms4 J AM IL AH 1. Wonink HA et al. 2023
Slide 7: Clinical Data Review
Clinical Data Review L U C T R U YE N
Slide 8: Innovative ADHERE Study Design
Innovative ADHERE Study Design Identify patients with active CIDP Confirm IgG involvement Assess efficacy & safety Screening Treatment Period Randomized, ≤4 WEEKS Open-label placebo-controlled Clinical Confirmation Stage A (N=322) Stage B (N=221) Committee 99% RESPONDERS ONLY ADVANCE TO STAGE B VYVG
Slide 9: Key Data from ADHERE Trial
Key Data from ADHERE Trial STAGE A STAGE B HR: 0.39 61% Probability(%) of No Clinical Worsening 40% Time to Improvement reduced risk P = < 0.0001 Demonstrated improvement by of relapse Week 4 Consistent 2/3 response across subgroups Improved / progressed to Stage B 9
Slide 10: Patients Experienced Deep and Clinically Meaningful Improvements in Functional Ability
Patients Experienced Deep and Clinically Meaningful Improvements in Functional Ability ~30% patients able to improve 3-4 points on INCAT** INCAT Disability Scale: Arm Disability* Functional Ability (aINCAT) Cumulativ e Frequency of Stage B Best Improv ement f rom Stage A Baseline (n=110) Ef gartigim
Slide 11: ADHERE Trial Safety: Summary of Adverse Events
ADHERE Trial Safety: Summary of Adverse Events Open-Label Stage A Double-Blinded Stage B Efgartigimod PH20 SC Efgartigimod PH20 SC Placebo n (% ) (N=322; PYFU=46.9) (N=111; PYFU=56.7) (N=110; PYFU=42.1) PARTICIPANT WITH EVENT Any TEAE 204 (63.4) 71 (64.0) 62 (56.4) Any SAE 21 (6.5) 6 (5.4) 6 (5.5) I
Slide 12: Commercial Strategy
Commercial Strategy K A R E N MA S S E Y
Slide 13: Raising Expectations for CIDP Patients
Raising Expectations for CIDP Patients “ “Every day is your new normal. I had to learn how to continue life - every single day - even though things are going to be different for me.” SCOTT- CIDP PATIENT 13
Slide 14: Maximizing Impact of VYVGART Hytrulo
Maximizing Impact of VYVGART Hytrulo Empower Patients Provide Best in Drive Rapid Deliver Broad to Demand more Class Patient Healthcare Provider Access from their Treatment Support Adoption 14
Slide 15: 12,000 Adult CIDP Patients in U.S. Not Well-Managed with Current Treatment Options
12,000 Adult CIDP Patients in U.S. Not Well-Managed with Current Treatment Options Diagnosed CIDP Patients ~41K Treated CIDP Patients Includes all patients treated on IVIG/SCIG, PLEX, steroids, biologics, other ~24K Patients Not Well-Managed on Current Therapy* ~12K *This is defined as patients w ho
Slide 16: Activating an Empowered Patient Community
Activating an Empowered Patient Community 16
Slide 17: Driving Rapid Adoption with Neurologists
Driving Rapid Adoption with Neurologists Neurology Landscape Reaching the Right Physicians • Expansion of deeply experienced sales force • Strong relationships with existing VYVGART prescribers Leveraging the Strength of ADHERE data • First innovation in 30 years • Compelling combined safety, effica
Slide 18: Securing Broad Access
Securing Broad Access Establishing Value Based Agreements Net Revenue Per Patient Ability to leverage existing established relationships with payors Real World Utilization Payor Mix - CIDP VBA designed to cap the exposure of Established % of patients Data payors based on number of vials per year pri
Slide 19: Multidimensional Expansion in CIDP
Multidimensional Expansion in CIDP VYVGART® Hytrulo Approved June 21, 2024 Pre-filled syringe (PFS) filed June 2024 Expected Decisions on Approval 2025 Filing submitted (VYVDURA) April 2024 Zai Lab announced acceptance of sBLA in China May 2024 Submission filed with EMA June 2024 19
Slide 20: Looking Ahead
Looking Ahead T I M VA N H A U W E R ME I R E N
Slide 21: Where Innovation Meets Critical Unmet Need
Where Innovation Meets Critical Unmet Need Patient Science 21